B03-JA-Sole-Source-FAR-Part-13.5-Blue-Phantom-Redacted.docx

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: The contracting activity responsible for this action is the United States Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702.

2. Description of Action: The Telemedicine and Advanced Technology Research Center (TATRC), Medical Modeling, Simulation, Informatics, & Visualization (MMSIV) unit requests a new Firm-Fixed Price Contract for Blue Phantom Ultrasound Training Models; Brand Name Only. Funds are available under PR No. 0011646020 for $9,959.22 dated 6 May 2021, and PR No. 0011666354 for $24,336.00 dated 24 June 2021. This requirement will be fully funded with 2-Year (2020-2021) Defense Health Program Enhanced Funds.

3. Description of Supplies/Services: The Brand Name requested is Blue Phantom under their Ultrasound Training Model products to include:

CLIN 0001 Thoracentesis and Thoracostomy Ultrasound Training Model. Catalog Number: BPTT1000-1 Torso for practicing ultrasound guided thoracentesis with anterior and lateral ports for placing chest tubes. QTY: 1 Each @ $ 3,914.78

CLIN 0002 Bone Fracture Ultrasound Training Block with Crepitus. Catalog Number: BPBF200-C Block model for learning ultrasound imaging of crepitus bone fracture.

QTY: 1 Each @ $908.00

CLIN 0003 Bone Fracture Ultrasound Training Block with Greenstick. Catalog No.: BPBF200-G Block model for learning ultrasound imaging of greenstick bone fracture. QTY: 1 Each @ $908.00

CLIN 0004 Foreign Body Identification Ultrasound Training Block. Catalog No.: BPFB140 Block model for learning to identify foreign objects with ultrasound.

QTY: 1 Each @ $908.00

CLIN 0005 Branched 4-Vessel Ultrasound Training Block Catalog No.: BPBV110 Block model for practicing ultrasound guided vascular access. QTY: 1 Each @ $513.86

CLIN 0006 Yellow Ultrasound Refill Fluid (1 liter) Catalog No.: BRS183-YELOW-1LTR One 1-Liter bottle of yellow refill fluid to simulate bodily fluid. Blue Phantom fluid is specially formulated to prohibit bacterial growth in the phantoms. QTY: 1 Each @ $102.46

CLIN 0007 Thoracentesis Lateral Portal Replacement Insert. Catalog No. BPTT1004 Replacement lateral portal insert for BPTT1000-1. QTY: 2 Each @ $178.10

Extended Total: $356.20

CLIN 0008 Thoracentesis Anterior Portal Replacement Insert. Catalog No: BPTT1003 Replacement anterior portal insert for BPTT1000-1. QTY: 2 Each @ $178.10 Extended Total: $356.20

CLIN 0009 Thoracentesis Replacement Insert. Catalog Number: BPTT1002 Replacement tissue insert for BPTT1000-1. QTY: 1 Each @ $2,432.66

CLIN 0010 FAST Exam Ultrasound Training Model. Catalog No: BPFAST1800 Full torso for learning ultrasound imaging of Focused Assessment with Sonography in Trauma (FAST) and practicing ultrasound guided aspirations of free fluid. Not compatible with transesophageal imaging. QTY: 1 Each @ $24,336.00

Grand Total: $34,295.22

Name of Suggested Contractor and Address:

CAE Healthcare Inc. 6300 Edgelake Drive Sarasota, FL 34240

Phone: 1-941-377-5562 Duns: 95-789-8471 Cage Code: 1LLZ4 TIN: 22-343-7089

4. Authority Cited: Statutory authority permitting other than full and open competition: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: Only one Brand Name, Blue Phantom; is capable of meeting the Ultrasound Training Model products required. CAE Healthcare Inc. is the sole manufacturer of Blue Phantom Ultrasound Training Models, which support ultrasound-guided interventions and blind insertion techniques for approximately twenty medical specialties. These Blue Phantom training models are also built with the patented SimulexUS™ self-sealing tissue, which image like real tissue utilizing any clinical ultrasound system. The Blue Phantom Ultrasound training models are top of the line ultrasound products; the quality alone is a major benefit for receiving realistic imaging. It is the only FAST Exam ultrasound training model that includes the entire torso as well as the head and face in realistic quality while also having the patented SimulexUS™ self-sealing tissue. SimulexUS™ is specifically designed to match the acoustic properties of human tissue, therefore; you can use virtually any ultrasound system with a Blue Phantom model and you will receive a realistic ultrasound image.

These ultrasound models will be used in TATRC’s research for robotic and autonomous systems and their ability to perform patient care tasks. Autonomous systems will be controlled through vision and perception sensors. The robotic and autonomous systems must perceive a realistic mannequin in order to properly orientate an ultrasound probe on the training torso. This limits the minimum requirements of a ultrasound phantom to being capable of training/demonstrating the FAST Exam, providing high quality ultrasound imaging, and having a realistic human form torso, head and face for an autonomous system to recognize a human. The following are the specific Blue Phantom products requested by TATRC:

The Thoracentesis Ultrasound Training Model includes a full body torso mannequin with head and face included for a realistic ultrasound imaging and diagnostics experience.

The model offers ultra-realism for the Thoracentesis procedure via ultrasound training but also accommodates Transthoracic Echocardiography (TTE) and Pericardiocentesis procedural training.

The Bone Fracture Ultrasound Training Model includes a table top bone fracture block model for a realistic ultrasound imaging and diagnostics experience. The model offers ultra-realism for visualization of bone fracture via ultrasound training. It is a research requirement for TATRC to acquire an ultrasound phantom capable of demonstrating and training a bone fracture diagnosis during a trauma exam. This ultrasound model will be used in TATRC’s research for data collection and human and machine interfacing and their ability to perform patient care tasks. The robotic and autonomous systems must perceive a realistic mannequin in order to properly orientate an ultrasound probe on the training block.

The Greenstick Bone Fracture Ultrasound Training Model includes a Greenstick Bone Fracture block model for a realistic ultrasound imaging and diagnostics experience. It is a research requirement for TATRC to acquire an ultrasound phantom capable of demonstrating and training a bone fracture diagnosis during a trauma exam and practice of Advanced Trauma Life Support (ATLS) protocols and procedures and are IAW Tactical Combat Casualty Care guidelines.

The Foreign Body Identification Ultrasound Training Model includes a table top foreign body block model for a realistic ultrasound imaging and diagnostics experience. The model offers ultra-realism for visualization of foreign bodies via ultrasound training. It is a research requirement for TATRC to acquire an ultrasound phantom capable of demonstrating and training a foreign body’s diagnosis during a trauma exam and practice of Advanced Trauma Life Support (ATLS) protocols and procedures and are IAW Tactical Combat Casualty Care guidelines.

The Branched 4-Vessel Vascular Access Training Model includes a table top Branched 4 vessel vascular access training model for a realistic ultrasound imaging and diagnostics experience. The model offers ultra-realism for visualization of Branched 4 vessel vasculature via ultrasound training. It is a research requirement for TATRC to acquire an ultrasound phantom capable of demonstrating and training a vascular access in a trauma case situation and practice of Advanced Trauma Life Support (ATLS) protocols and procedures and are IAW Tactical Combat Casualty Care guidelines.

The Yellow Ultrasound Refill Fluid is specifically designed for the Blue Phantom Thoracentesis ultrasound training model. It is a research requirement for TATRC to acquire an ultrasound phantom capable of demonstrating and training Thoracentesis procedures in a trauma case situation and practice of Advanced Trauma Life Support (ATLS) protocols and procedures and are IAW Tactical Combat Casualty Care guidelines. Blue Phantom Yellow Fluid Refill is compatible with the Blue Phantom training models. This ultrasound model will be used in TATRC’s research for data collection and human and machine interfacing and their ability to perform patient care tasks. Autonomous systems will be controlled through vision and perception sensors. The robotic and autonomous systems must perceive a realistic fluid in order to properly recognize serum fluid via ultrasound probe on the training model.

The Thoracentesis Model Lateral Replacement Insert and the Thoracentesis Anterior Portal Replacement Insert are specifically designed for the Blue Phantom Thoracentesis ultrasound training model. It is a research requirement for TATRC to acquire an ultrasound phantom capable of demonstrating and training Thoracentesis and Thoracotomy procedures in a trauma case situation and practice of Advanced Trauma Life Support (ATLS) protocols and procedures that are IAW Tactical Combat Casualty Care guidelines. Blue Phantom lateral portal replacement and anterior portal replacement inserts are compatible with the Blue Phantom thoracentesis training models. The robotic and autonomous systems must perceive a realistic feel in order to properly recognize and place a needle or chest tube via an ultrasound probe on the training model.

The Thoracentesis Model Tissue Replacement Insert is specifically designed for the Blue Phantom Thoracentesis ultrasound training model. It is a research requirement for TATRC to acquire an ultrasound phantom capable of demonstrating and training Thoracentesis and Thoracotomy procedures in a trauma case situation and practice of Advanced Trauma Life Support (ATLS) protocols and procedures that are IAW Tactical Combat Casualty Care guidelines. The Blue Phantom tissue replacement insert is compatible with the Blue Phantom thoracentesis training models. The robotic and autonomous systems must perceive a realistic feel in order to properly recognize and place a needle or chest tube via an ultrasound probe on the training model.

The FAST Exam Real Time Ultrasound Training Model includes a full body torso mannequin with head and face included with self-sealing tissue for a realistic ultrasound imaging and diagnostics experience. The model offers ultra-realism for the Focused Assessment with Sonography for Trauma ultrasound training but also accommodates Transthoracic Echocardiography (TTE) and Pericardiocentesis procedural training. It is a research requirement for TATRC to acquire an ultrasound phantom that is capable of demonstrating and training the FAST exam.

Failure to acquire the Blue Phantom ultrasound task-trainers and consumables would not permit the completion of research and development activities for the TATRC simulation lab, which would result in mission failure.

6. Efforts to Obtain Competition: This requirement will be posted out on SAM.gov as unrestricted with this redacted SSJ for a Brand Name Only requirement for Blue Phantom products. For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to an exception at 5.202(a)(13).

7. Actions to Increase Competition: There are no planned subsequent acquisitions for the required products beyond this purchase order. However; market research will be conducted prior to any further acquisitions, to ascertain if there are changes in the market place, to research other vendors to see if they are capable of fulfilling the Government’s requirement, and to promote maximum competition.

8. Market Research: In March 2021 the TATRC MMSIV team reviewed the recently updated medical simulation distributer magazines Limbs and Things, Pocket Nurse, and American Rescue. None of the catalogs had Blue Phantom products nor products that would accurately meet the requirements. Additional Market Research in August by TATRC explored online options including a Google search that showed multiple resellers are available where the Brand Named Blue Phantom devices could be purchased. The search found multiple resellers who had most, if not all; of the items requested. Besides CAE Healthcare Inc., another company called Anatomy Warehouse was found to have all the products requested available for purchase. GSA was also searched and there were no Blue Phantom products available. Additional market research via phone in September found the vendor CAE Healthcare Inc. to be the manufacturer for this requirement. As there appear to be multiple resellers available, a Brand Name Only solicitation shall be posted out on SAM.gov to provide maximum competition for the Blue Phantom Ultrasound Training Model products.

9. Interested Sources: To date, no other sources have written to express an interest in this acquisition. The notices required by FAR 5.201 shall not be published as indicated in Section 7 as the exception in 5.202(a)(13) applies.

Control Number: JA-21-08-1052

CUI

Blue Phantom Ultrasound Training Model products for TATRC in Frederick, MD

(Source Selection information - See FAR 2.101 and 3.104-4)

APR 2021

The requirement to post this justification in accordance with FAR 13.105(c): This Action is a brand name restriction, over $25K. The justification will be redacted and posted with the solicitation.

10. Other Facts:

a. Procurement history. Not Applicable. This is a new requirement.

b. Other facts. None.

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: Date: _8 September 2021MANEMEIT.CARL.HENRY.10 Digitally signed by 14375208 MANEMEIT.CARL.HENRY.1014375208 Date: 2021.09.08 15:32:17 -04'00'

Typed Name: _ Carl Manemeit Title: _ Deputy Division Chief _

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: Date: _8 September 2021MANEMEIT.CARL.HENRY.10 Digitally signed by 14375208 MANEMEIT.CARL.HENRY.1014375208 Date: 2021.09.08 15:32:17 -04'00'

Typed Name: _ Carl Manemeit Title: _ Deputy Division Chief

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable according to the price analysis technique of comparing vendor’s quotes against one another. Certified cost or pricing data is not required per FAR 15.403-1(b)(3).

HELMAN.CHRISTINE.

Digitally signed by HELMAN.CHRISTINE.E.1228992972

Signature: E.1228992972 Date: 2021.09.08 16:11:13 -04'00' Date: _8 September 2021

Typed Name: _Christine E. Helman Title: Contracting Officer

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

HBlEuLeMPAhaNn.tCoHmRUISltTrIaNsoEu. DnigditaTllryasiignniendgbyModel products for TATRC in Frederick, MD

HELMAN.CHRISTINE.E.1228992972

Control Number: JA-21-08-1052

(Source Selection information - See FAR 2.101 and 3.104-4)

APR 2021

Signature: E.1228992972 Date: 2021.09.08 16:11:3_5 -04'00'

Date: _8 September 2021

Typed Name: _Christine E. Helman Title: $Contracting Officer